1. Vinod K. Bhutani, MD, FAAP Professor of Pediatrics Division of Neonatal and Developmental Medicine Lucile Packard Children’s Hospital Stanford University, Stanford, CA Newborn Jaundice and the Prevention of Kernicterus A Six-Sigma Approach Supported by AAMC/CDC: MM0048

3. Review of a Kernicterus Case Reported to the Pilot Registry (Institute Of Medicine m atrix) Lack of on-site lactation consultation Lack of - documentation - response of laboratory staff Case # GWB (from a convenient sample of 125 cases (Kernicterus Registry) CHARACTERIZATION Lack of response to parent’s report . Lack of communication among professionals Lack of jaundice teaching Patient Centeredness Lack of consistent discharge plan. Lack of TSB/TcB measure jaundice progression Lack of hospital based breastfeeding Lack of recognition of jaundice as a vital sign Lack of recognition for clinical risk factors Lack of jaundice recognition for TSB or TcB Timeliness Effective Care Safety

4. IDENTIFICATION

5. AAP: Jay Berkelhammer (President): Wall Street Journal (Letter to the Editor) CDC: website. www.cdc.gov/kernicterus JCAHO: Sentinel Alert www.jcaho.org/kernicterus Clinical Practice: Quality Indicators Available tool-kits. AAP/CDC/CPQCC Practice Guidelines and Family Education OPTMIIZATION

7. TSB ≥30 mg/dL (Sentinel Event) SURVEILLANCE zero 2001-2005 Community-based systems program Brazil (SP) zero 1990-2003 Hospital based systems program USA (PA) Frequency Study period Health practice Regions 1 in 10,000 1995-1998 HMO (retrospective) USA (CA) 1 in 14,651 2003 Health system review USA (HCA) 1 in 10,000 2002-2004 National survey Canada 1 in 14,084 2003-2005 National review (home follow-up) UK

9. Systems-approach to Prevent Kernicterus: A Health-Societal Strategy Identification Characterization Optimization Cases of Kernicterus National AAP Guidelines Educational Tool-kits (eg: CDC/ AAP/CPQCC) To Achieve Safety Standards 1 2 3 4 5 6

10. Systems-approach to Prevent Kernicterus: A Community-Based Approach Identification Characterization Optimization Outcomes Surveillance Cases of Kernicterus National AAP Guidelines Educational Tool-kits (eg: CPQCC) - Exchange Tx - Readmit rate TSB ≥ 25 mg/dL or, Sentinel event To Achieve Safety Standards 1 2 3 4 5 6 Implementation At Pediatrician’s offices / clinics/ and homes ? A Six-sigma Approach

15. IDENTIFICATION

18. Clinical Risk Factors for Severe Hyperbilirubinemia Supposedly a baby who is not at (clinical or epidemiological) risk for hyperbilirubinemia is: A white, anglo-saxon, female neonate, who is exclusively formula-fed, who has no bruising, does not have a sibling with jaundice and in whom there is no ABO / Rh, minor blood group incompatibility or other evidence of hemolysis. Case report of Kernicterus in one such baby (Pilot Kernicterus Registry) CHARACTERIZATION

19. 19 22.5 25 OPTIMIZATION

20. OPTIMIZATION Term AGA Girl (BW=3742gms and GA = 39wks), spont. Vaginal delivery. Extensive bruising and cephalhematoma. No blood group incompatibility. Breast fed.Idiopathic jaundice. BAER: wnl INTENSIVE PHOTOTHERAPY TSB 22 mg/dl at age 128 hrs. : Intensive phototherapy started Lesson Learned: CASE STUDY (1999) ▲ ▲ ▲ ▲ ▲ ▲ ▲

24. 1: 2317 1: 1322 1: 1637 1:3198 1: 1827 1: 11,995 Study Cohort Current Systems-approach Program development Evolution of Phototherapy and Exchange Transfusion Use with Systems-approach Selective TSB COMPARISON Pennsylvania Hospital: 1990-2003 Practice OUTCOME

25. SURVEILLANCE

26. Jerusalem’s Hospital-community Initiative for Newborn Jaundice Management Kaplan et al 2007. J of Peds Community SURVEILLANCE

29. Proposal: A Nation-wide strategy to Prevent Kernicterus in USA (a close call) (universal screen)